Transcatheter delivery of a replacement heart valve

ABSTRACT

A replacement heart valve apparatus. The heart valve apparatus includes a stent and a valve frame having a substantially cylindrical body defining a lumen. The valve frame includes a plurality of curved wire pairs attached to the substantially cylindrical body. Each curved wire pair includes an inner curved wire and an outer curved wire. The wire frame further having a plurality of leaflets. Each leaflet is attached to a respective inner curved wire and extends over a respective outer curved wire, so as to position the body of the leaflet within the lumen of the valve frame.

RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/052,466, filed on Feb. 7, 2005, now U.S. Pat. No. 7,470,285 whichclaims the benefit of and priority to U.S. Provisional PatentApplication Ser. Nos. 60/542,008, filed on Feb. 5, 2004; 60/575,167,filed on May 28, 2004; and 60/610,271, filed on Sep. 16, 2004, eachowned by the assignee of the present application, and the entire contentof each of which is herein incorporated by reference.

TECHNICAL FIELD

The present technology relates generally to the treatment of heart valvedysfunction and, in particular, to minimally invasive systems andmethods for replacing such heart valves.

BACKGROUND IF THE INVENTION

Treatment of congenital heart disease typically requires surgicalintervention, such as “open-heart” surgery during which the thoraciccavity is opened and the heart, arteries/veins and/or associated valvesare repaired or otherwise treated. Postoperative complications that mayappear during short and long-term patient follow-up include heart valvedysfunction. For example, tetrology of fallot is a congenital heartdefect often discovered at birth, in which a baby appears blue as aresult of an obstruction affecting the proper functioning of thepulmonary valve of the heart. The obstruction is often surgicallyremoved at an early age to improve the chances that the baby willsurvive. The surgical procedure typically results in subsequent leaking(i.e., regurgitation) of blood through the pulmonary valve. Over thelife of the patient, the regurgitation may become more severe and resultin further dysfunction of the heart valve due to, for example, dilationof the heart chamber and heart valve, by the body, to compensate for theincreased regurgitation.

Approximately 89,000-95,000 open-heart surgeries are performed each yearto address and resolve heart valve dysfunction. The surgery requires anincision, under general anesthesia, that transects the sternum in halfvertically from just below the larynx to above the diaphragm. The heartis stopped or arrested during the surgery by infusing cold saline withhigh potassium content. A heart-lung machine then drains thedeoxygenated blood from a tube placed in the right atrium and pumps itthrough an oxygenator. The oxygenator has a blood gas membrane thatallows carbon dioxide to leave the blood while oxygen is diffused intothe blood. The oxygenated blood is then returned to the patient througha tube that runs into the aorta, above the valve. This surgery is veryexpensive and requires a prolonged recovery period in the hospital withadditional rehabilitation once the patient is discharged. This invasivesurgery also results in a large chest scar.

Heart valve dysfunction includes, for example, pulmonary regurgitation,which occurs when the heart valve in the main pulmonary artery betweenthe heart and the lungs, is unable to prevent the backflow of blood tothe right ventricle of the heart. The dysfunction of this heart valveleads to a volume load on the right ventricle and causes rightventricular dilation, which can lead to right ventricular dysfunctionwhich is thought to contribute to ventricular tachycardia and suddendeath.

Due to the long-term deleterious effects of severe pulmonaryregurgitation, surgical pulmonary valve replacement is performed forpatients with severe regurgitation, symptoms of exercise intoleranceand/or progressive right ventricular dilation and dysfunction.

Cardiologists typically defer the valve replacement procedure as long aspossible, because of: the need for a repeat open-heart surgery; therisks of surgery and cardiopulmonary bypass; and the limited lifespan ofall available surgically-implanted valves. The risks associated withsurgical valve replacement are particularly acute with respect topediatric patients in that the replacement valves do not grow with thepatient and thus require more frequent replacement.

Prosthetic heart valves used to replace diseased or abnormal naturalheart valves are typically mechanical devices with, for example, a rigidorifice ring and rigid hinged leaflets or ball-and-cage assemblies.Prosthetic heart valves are, more recently, bioprosthetic devices thatcombine a mechanical assembly with biological material (e.g., human,porcine, bovine, or biopolymer leaflets). Many bioprosthetic valvesinclude an additional support structure, such as a stent, to support theleaflets of the valve. The stent also absorbs the stresses, which wouldotherwise be borne by the leaflets, from the hemodynamic pressureexerted during normal heart operation.

Heart valve replacement, typically, involves the surgical implantationof the valve prosthesis during open heart surgery and requires the useof a heart and lung machine for external circulation of the blood as theheart is stopped and the artificial valve prosthesis is sewed in. Valvereplacement surgery is thus very demanding on the patient's body andmay, therefore, not be a viable technique for patients that arephysically weak due to age or illness. Accordingly, it is desirable todevelop a heart valve replacement apparatus and procedure that isminimally invasive and does not have the morbidity of a re-operation.

SUMMARY

Replacement heart valves and supporting structures, made and used inaccordance with the disclosed technology, enable cardiologists toimplement minimally invasive procedures that avoid the morbidity of are-operation.

In one embodiment, an apparatus made in accordance with the disclosedtechnology enables the transcatheter delivery of a replacement heartvalve. The apparatus includes an introducing catheter, a stent and avalve frame. The stent is adapted to receive the valve frame and isdeployable within an anatomical lumen of the heart via the introducingcatheter prior to the stent receiving and supporting the valve frame. Inone aspect, the stent has a barrel or sinus shape when opened so as tomimic the physiological shape of a human heart valve. In another aspect,a balloon catheter expands the stent once it is withdrawn from theintroducing catheter. In another aspect, the stent self-expands once itis withdrawn from the introducing catheter.

In one embodiment, a stent made in accordance with the disclosedtechnology enables the transcatheter delivery of a valve frame. Thestent includes a plurality of securing structures or materials (e.g.,sutures or adhesive), where each such securing structure or material isadapted to receive and support one of a plurality of valve frames.

The two-part methodology discussed above, where the stent is deployedfirst and the valve frame is deployed and affixed to the stent second,enables the introducing catheter to be a relatively small French sizeand reduces the distortion of the replacement heart valve duringimplantation. The stent also enables multiple valve frame replacementswithout replacing the stent and maintains precise valve frame alignmentrelative to the stent when deployed within the anatomical lumen.

In one embodiment, the disclosed technology enables a minimally invasivemethod of implanting a replacement heart valve. In one aspect, a valveassembly is deployed within an anatomical lumen of the heart via anintroducing catheter. The valve assembly is a unitary body possessingthe functionality of both a stent and a valve frame.

In general, in another aspect, the invention involves a prosthetic valvefor altering the flow of blood through a blood vessel of a heart. Thevalve includes a stent that has a first, generally cylindrical body. Thefirst, generally cylindrical body has a first mesh and defines a firstlumen. The first lumen extends along the length of the first, generallycylindrical body. The valve also has a valve frame that is positionableco-axially within the first lumen of the stent. The valve frame has asecond, generally cylindrical body that has a second mesh. The second,generally cylindrical body defines a second lumen and a plurality ofleaflets. The second lumen extends along the length of the second,generally cylindrical body.

Embodiments of this aspect of the invention can include the followingfeatures. The first, generally cylindrical body of the prosthetic valvecan define a region that protrudes from the first, generally cylindricalbody. The region can be a plurality of regions. The plurality ofleaflets of the prosthetic valve can be located at one end of thesecond, generally cylindrical body.

In general, in another aspect, the invention involves a prosthetic valvefor altering the flow of blood through a blood vessel of a heart. Thevalve includes a valve assembly that has a generally cylindrical body.The generally cylindrical body has a mesh and a plurality of leaflets.The generally cylindrical body defines a lumen that extends along thelength of the generally cylindrical body.

Embodiments of this aspect of the invention can include the followingfeatures. The generally cylindrical body of the prosthetic valve candefine a region that protrudes from the generally cylindrical body. Theregion can be a plurality of regions. The plurality of leaflets of theprosthetic valve can be located at one end of the generally cylindricalbody.

In another aspect, an apparatus made in accordance with the disclosedtechnology enables the transcatheter delivery of a replacement heartvalve. The apparatus includes a stent having a bulbous proximal end anda distal end with a neck extending therebetween, the distal end of theneck defining a tapered portion. Also included in the device is a valveframe receivable within a lumen of the stent where a distal end of thevalve frame is engageable with the tapered portion of the stent andwhere valve members of the valve frame are engageable with the bulbousproximal end of the stent.

In another embodiment the invention relates to a replacement heart valveapparatus including a stent and a valve frame. The valve frame has asubstantially cylindrical body defining a lumen and having a pluralityof curved wire pairs attached at one end of the substantiallycylindrical body. Each curved wire pair includes an inner curved wireand an outer curved wire. The wire frame has a plurality of leaflets.Each leaflet is attached to a respective inner curved wire and extendsover a respective outer curved wire, to be positioned within the lumenof the valve frame.

These and other objects, along with the features of the presentinvention herein disclosed, will become apparent through reference tothe following description, the accompanying drawings, and the claims.Furthermore, it is to be understood that the features of the variousembodiments described herein are not mutually exclusive and can exist invarious combinations and permutations.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, like reference characters generally refer to the sameparts throughout the different views. Also, the drawings are notnecessarily to scale, emphasis generally being placed upon illustratingthe principles of the invention. In the following description, variousembodiments of the present invention are described with reference to thefollowing drawings, in which:

FIG. 1 is a partially broken-away view of a heart showing the typicallocation of various heart valves.

FIG. 2A is a top-view of a natural heart valve.

FIG. 2B is a partially broken-away isometric view of a natural heartvalve.

FIG. 3A is a top-view of an embodiment of a stent according to theinvention.

FIG. 3B is a side-view of the stent of FIG. 3A.

FIG. 4A is a top-view of an embodiment of a valve frame according to theinvention.

FIG. 4B is a side-view of the valve frame of FIG. 4A

FIG. 5A is a top-view of the valve frame of FIG. 4A located within alumen of the stent of FIG. 3A.

FIG. 5B is a side-view of the valve frame and stent of FIG. 5A.

FIG. 5C is a top-view of the valve frame and stent of FIG. 5A with themembers of the valve frame covered with a cover material and free endsof the cover material located away from the wall of the stent.

FIG. 5D is a cross-sectional view of the valve frame and stent of FIG.5C.

FIG. 5E is a top-view of the valve frame and stent of FIG. 5C with thefree ends of the cover material located towards the wall of the stent.

FIG. 5F is a cross-sectional view of the valve frame and stent of FIG.5E.

FIG. 6 is a partially broken-away view of a heart subsequent toinsertion of an introducing catheter into the heart.

FIG. 7 is a partially broken-away view of the heart of FIG. 6 subsequentto placement of a stent and balloon in a predetermined location of ananatomical lumen of the heart.

FIG. 8 is a partially broken-away view of the heart of FIGS. 6 and 7subsequent to the stent and balloon being deployed in the heart.

FIG. 9 is a partially broken-away view of the heart of FIGS. 6, 7 and 8subsequent a valve frame being introduced into the introducing catheter.

FIG. 10 is a partially broken-away view of the heart of FIGS. 6, 7, 8and 9 subsequent to the deployment of the valve frame within the stent.

FIG. 11A is a top-view of an embodiment of a valve assembly according tothe invention.

FIG. 11B is a side-view of the valve assembly of FIG. 11A.

FIG. 11C is a cross-sectional view of the valve assembly of FIG. 11Bwith a cover material applied to the valve assembly.

FIG. 12A is a side-view of an embodiment of a valve assembly accordingto the invention.

FIG. 12B is a cross-sectional view of the valve assembly of FIG. 12Awith a cover material applied to the valve assembly.

FIG. 13A is a top view of a digital image of a model of a valve frame,such as the valve frame of FIG. 5C.

FIG. 13B is a side-view of a digital image of a model of a valve frame,such as the valve frame of FIG. 5C.

FIG. 14A is a top view of a digital image of a model of a valveassembly, such as the valve assembly of FIG. 11A.

FIG. 14B is a side-view of a digital image of a model of a valveassembly, such as the valve assembly of FIG. 11B.

FIG. 15A is a top view of a digital image of a model of a valveassembly, such as the valve assembly of FIG. 12A.

FIG. 15B is a side view of a digital image of a model of a valveassembly, such as the valve assembly of FIG. 12A.

FIG. 16 is a side-view of a stent in accordance with one embodiment ofthe invention.

FIG. 17 is a side-view of a valve frame in accordance with oneembodiment of the invention.

FIGS. 18A-18E are side-views of a valve frame being deployed by catheterinto the stent of FIG. 16 in accordance with one embodiment of theinvention.

FIGS. 19A-19E are side-views of docking stations for receiving medicaldevices or drugs.

FIGS. 20A-20F are side-views of docking stations inserted into the bodyat various locations.

FIG. 21 is a view of an embodiment of the stent and the valve frame(without) leaflets) of the invention.

FIG. 22 is an opened view of a portion of another embodiment of thevalve frame (without leaflets) of the invention.

FIG. 23 is a plan view of the embodiment of the valve frame of FIG. 22with leaflets attached.

FIG. 24 is a plan view of a leaflet.

FIG. 25 is a cross-sectional view through line AA′ of FIG. 23 showingthe attachment of the leaflet to the inner curved wire and the placementof the leaflet over the outer curved wire.

FIG. 26 is an opened view of a portion of another embodiment of thevalve frame (without leaflets) of the invention.

DETAILED DESCRIPTION

In brief overview and with reference to FIG. 1, the heart has fourchambers and is located in the middle of the chest with a slight tilttoward the left side. Deoxygenated blood (containing low oxygen) returnsfrom the entire body via the superior and inferior branches of the venacava emptying into the right atrium. During diastole, or the relaxationphase of the cardiac cycle, pressure in the right ventricle falls frombetween about 20 mm Hg and about 30 mm Hg to between about 5 mm Hg andabout 10 mm Hg. The pressure gradient formed between the right atriumand right ventricle, plus the contraction of the atrium, causes forwardflow of blood through the tricuspid valve into the right ventricle. Theflow of blood through the tricuspid valve thereby fills the rightventricle with blood. During systole, the pumping phase of the cycle,the right ventricle starts to contract, increasing intraventricularpressure. This causes the tricuspid valve to snap shut and the cusps ofthe pulmonary valve to open. Blood then flows out of the right ventriclethrough the pulmonary artery into the lungs where oxygenation occurs andcarbon dioxide is removed.

The cycle of blood flow starts against with relaxation of the rightventricle. Because the diastolic pressure (e.g., less than about 5 mmHg) in the right ventricle is lower than the pulmonary artery pressure(e.g., about 10 mm Hg) the pulmonary valve closes and preventsregurgitation. Simultaneously with the fall in the pressure in the rightventricle, the tricuspid valve opens and again fills the rightventricle.

Once the blood has been oxygenated, it flows into the left side of theheart via the pulmonary veins into the left atrium. It is duringdiastole that blood flows through the mitral valve into the leftventricle. During systole, the pressure in the left ventricle causes themitral valve leaflets to close and the aortic valve to open. The bloodflows out of the aorta for circulation throughout the body.

The geometry and circuitry of the two sides of the heart are similar;however the function of each is different. The right side pumps bloodonly to the lungs for gas exchange. The left side pumps blood to theentire body. The left side generates pressures three to four timesgreater than the right side.

As discussed, there are four valves within the human heart, located atthe exit of each chamber. In order of blood flow, they are the tricuspid(right atrium), pulmonary (right ventricle), mitral (left atrium) andaortic valves (left ventricle). Due to the higher-pressure gradient, themitral and aortic valves are subject to greater fatigue and/or risk ofdisease. The aortic and pulmonary valves are similar anatomically andare referred to as semi-lunar valves.

As illustrated in FIGS. 2A and 2B, an aortic valve 21 is a semi-lunarvalve, named because of the partial moon-like shape of its three cusps20 a, 20 b and 20 c (generally 20). The three cusps 20 a, 20 b and 20 care soft tissue structures attached to a wall 23 of the aortic valve 21in an area designated as the annulus 22. During the contraction phase ofsystole, the three cusps 20 a, 20 b and 20 c are pushed back against thewall 23 of the aorta and blood flows (as illustrated in FIG. 2B) throughthe aortic valve 21. During diastole or relaxation of the ventricle, thepressure in the left ventricle falls and blood begins to flow backward(in the opposite direction to the blood flow indicated in FIG. 2B).During diastole, the left ventricular pressure falls and when thepressure is below the relaxation pressure of the aorta, the aortic valvecloses (the cusps 20 a, 20 b and 20 c fall away from the wall 23 andclose), thereby eliminating backward flow of the blood.

A unique feature of the aortic valve 21 is the presence of aorticsinuses in the region of the valve referred to as the root 26. There arethree sinuses 24 a, 24 b and 24 c that have an orifice at each of thecusps 20 a, 20 b and 20 c, respectively. These barrel-shaped regions ororifices located in the sinuses 24 a, 24 b and 24 c affect the fluiddynamics of blood in the area of the aortic valve 21 and may contributeto the opening and closing of the cusps 20 a, 20 b and 20 c of theaortic valve 21. Two of the cusps are named for branches of the maincoronary arteries for which the cusps act as openings (i.e., the leftand right coronary sinuses) and the third sinus is named thenon-coronary sinus. The three corresponding cusps 20 a, 20 b and 20 care named in a similar fashion.

The disclosed technology mitigates the potential complications ofinvasive surgery, by applying minimally invasive techniques to, forexample, replace a damaged natural heart valve with a replacement heartvalve. In one embodiment, a supporting structure, such as a stent orscaffold, is deployed at a preselected position within an anatomicallumen of the heart via an introducing catheter. The term “stent” and“docking station” are hereafter used to broadly refer to all types ofsupporting structures and scaffolds. The replacement heart valve is theninserted into the deployed stent using the same catheter or,alternatively, a second catheter. The stent and/or valve assemblyinclude attachment means (e.g., sutures or adhesive) to hold securelythe valve assembly in a desired orientation and alignment relative tothe stent. The two-part deployment of the stent and the heart valveenable the use of smaller catheters because the inner diameter of thecatheter need not accommodate, at the same point in time of theprocedure, the compressed volume of both a stent and a valve assembly.

As shown in FIGS. 3A and 3B, one embodiment of a stent 30 according tothe invention is made of a shape memory material. The stent 30 defines agenerally cylindrical body that has a wall 34 that is constructed from amesh 32. The wall 34 defines a lumen 36. The mesh 32 is constructedfrom, for example, wires or strips of shape memory material. By way ofexample, the shape memory material might be nickel-titanium wire soldunder the product name Nitinol. The nickel-titanium wire, when properlymanufactured, exhibits elastic properties that allow for the wire to bemanipulated (e.g., bent) by an operator and then returned to,substantially, the same shape the wire possessed prior to it beingmanipulated. The wire returns to, substantially, the same shape the wirepossessed prior to it being manipulated, for example, when the operatorheats the wire or, alternatively, when the operator removes the forcesapplied to bend the wire. In this embodiment, the stent 30 approximatesthe form of a cloverleaf to closely conform, for example, to thecloverleaf-like shape (associated with the three sinuses of a naturalheart valve) of the location in a heart where a defective heart valvehas been surgically removed.

The stent 30 could, alternatively, be any geometric shape (e.g.,cylindrical, conical, spherical or barrel-like) that is compatible withthe placement of the stent 30 within, for example, a lumen of the heart.The stent 30 could be manufactured using alternative materials (e.g.,stainless steel alloys, molybdenum alloys or pyrrolitic carbon) that arecompatible with placement in the body, that possess desirable materialwear properties and/or that have a minimal risk of causing infection inthe body of the patient.

FIGS. 4A and 4B illustrates one embodiment of a valve frame 40 indeployed form (i.e., not constrained by, for example, a wall of a lumenof a catheter used to introduce the valve frame 40 into the body). Thevalve frame 40 may be deployed within a stent, such as the stent 30 ofFIG. 3B. The valve frame 40 is made of a shape memory material. Thevalve frame 40 defines a, generally, cylindrical body that isconstructed from a mesh 42. The mesh 42 may be constructed from wires orstrips of a shape memory material. The valve frame 40 also has threevalve members 44 a, 44 b and 44 c. The valve members 44 a, 44 b and 44 chave a free end 48 a, 48 b and 48 c, respectively. The valve frame 40could, alternatively, be any geometric shape (e.g., cylindrical,conical, spherical or barrel-like) that is compatible with the placementof the valve frame 40 within a stent, such as the stent 30 of FIG. 3B.

As shown in FIGS. 5A and 5B, the valve frame 40 may be deployed withinthe lumen 36 of the stent 30 thereby creating a valve assembly 50. Inone embodiment, the valve assembly 50 may be deployed within a humanheart to replace a natural heart valve that may not function properly.The valve frame 40 would be manufactured to ensure that the valve frame40 would maintain a desired (e.g., fixed) placement with respect to thestent 30 when the valve frame 40 and the stent 30 are located within theheart of a patient and subjected to the flow of blood through the valveassembly 50. Referring now to FIGS. 5C and 5D, the valve members 44 a,44 b and 44 c would be coated, typically, with a cover material 56(e.g., a biocompatible material, such as, silicon rubber or bovine,porcine or human tissue that is chemically treated to minimize thelikelihood of rejection by the patient's immune system). The coatedvalve members 44 a, 44 b and 44 c would be capable of functioningsimilarly to the cusps 20 a, 20 b and 20 c of FIG. 2B. The covermaterial 56 may be a bio-engineered material that is capable of beingapplied to the valve members 44 a, 44 b and 44 c. The cover material 56would be applied to the valve frame 40 prior to deployment of the valveframe 40 into the body. The cover material 56 has three free ends 46 a,46 b and 46 c corresponding to valve members 44 a, 44 b and 44 c,respectively. The free ends 46 a, 46 b and 46 c also are referred to asleaflets. After placement of the valve frame 40 within the stent 30(located within the body) the cover material 56 applied to the valvemembers 44 a, 44 b and 44 c is capable of, generally, obstructing theflow of blood in the positive direction along the X-axis. The free ends46 a, 46 b and 46 c move away from the inner wall 34 of the stent 30,thereby limiting the flow of blood in the positive direction along theX-axis.

However, as blood flows in the negative direction along the X-axis,referring now to FIGS. 5E and 5F, the free ends 46 a, 46 b and 46 c ofthe cover material 56 move towards the inner wall 34 of the stent 30.The free ends 46 a, 46 b and 46 c, thereby substantially restrict theflow of blood through the valve assembly 50. In this manner, the valveassembly 50 approximates the functioning of a natural heart valve of thebody by allowing blood to flow in the negative direction along theX-axis.

FIGS. 13A and 13B are digital images of a model 130 of a valve frame,such as the valve frame 40 of FIG. 5C. For clarity of illustrationpurposes the valve frame model 130 is constructed from a tube 132 and asilicon rubber cover material 134. The valve frame model 130, referringnow to FIG. 13B, is cylindrical in shape. The valve frame model 130,alternatively, could be any geometric shape as described previouslyherein.

In more detail and with reference to FIG. 6, method steps associatedwith introducing an embodiment of the invention are described. Anintroducing catheter 61 is delivered via a femoral vessel to theinferior vena cava 63 by means of a guidewire 62 to a preselectedposition 68 in an anatomical lumen 65 of the heart. The preselectedposition 68 may be in proximity to the original location of a naturalheart valve. The introducing catheter 61 has an inner wall 69 thatdefines a lumen 64 through which the guidewire 62 is passed. Theintroducing catheter 61 has an opening 66 out of which the guidewire 62is extended. In one embodiment, the leaflets of the natural heart valveare removed prior to the insertion of the introducing catheter 61 intothe heart by resecting the leaflets intravenously (e.g., by inserting acutting and grasping device via a catheter to cut and remove theleaflets).

In another embodiment, the natural heart valve remains within the heart.With reference also to FIG. 7, a stent/balloon combination 71 isinserted into the introducing catheter 61 and is guided to thepreselected position 68 using the guidewire 62. The combination 71 isthen deployed from the confines of the introducing catheter 61 and islocated within the anatomical lumen 65. The stent/balloon combination 71includes a balloon 73 located within a lumen 75 of a stent 77. In oneembodiment, the stent/balloon combination 71 is positioned within theintroducing catheter 61 prior to inserting the introducing catheter 61into the anatomical lumen 65. In another embodiment, the stent/ballooncombination 71 is inserted into the introducing catheter 61 after theopening 66 of the introducing catheter 61 has been located at thepreselected position 68. In one embodiment, the preselected position 68corresponds to the sinus-shaped region of the anatomical lumen 65. Inanother embodiment, the preselected position 68 corresponds to a regionwithin the anatomical lumen 65 that is in substantial proximity to theoriginal position of the natural heart valve.

The balloon 73 of the deployed stent/balloon combination 71 is theninflated, referring now to FIG. 8, thereby expanding the stent 77 to apredetermined configuration and size. The expanded configuration of thestent 77 conforms to the sinus-shaped region of the anatomical lumen 65.In one embodiment, the size and shape of the sinus-shaped stent 77 issufficient to hold the stent 77 in a substantially fixed position andorientation within the anatomical lumen 65. In a further embodiment, thesinus-shaped stent 77 includes elements (e.g., sutures, hooks, spikes ortack tips) that attach to the interior walls of the anatomical lumen 65so as to more rigidly hold the stent 77 in a fixed position.

In another embodiment, the stent 77 is made of a shape memory material,such as a nickel-titanium wire, and self-expands when it is removed fromthe confines of the introducing catheter 61. Subsequent to deploying thestent 77 from the introducing catheter 61 the stent 77 expands to apredetermined size and shape because there are no longer anyconstraining forces (e.g., by the inner wall 69 of the introducingcatheter 61) applied to the stent 77.

Referring now to FIG. 9 and FIG. 10, a valve frame 91 is compressed andinserted into the introducing catheter 61 and the valve frame 91 isguided to the catheter orifice 66 and deployed into the lumen 75 of theexpanded stent 77. By way of example, in one embodiment the valve frame91 may be the valve frame 40 of FIG. 4A. The valve frame 91 expands uponbeing deployed from the introducing catheter 61 and assumessubstantially the same size and shape as the lumen 75 of the expandedstent 77. The stent 77 and/or valve frame 91 have attachment means thatserve to align and fix the valve frame 91 in the predetermined position68 within and with respect to the stent 77. Referring now to FIG. 10,the introducing catheter 61 is then removed from the anatomical lumen 65and the operation of the replacement valve is subsequently monitored.

In another embodiment, as illustrated in FIGS. 11A and 11B, a valveassembly 110 according to the invention is a unitary body that comprisesthe functionality of both a stent, such as the stent 30 of FIG. 3B, anda valve frame, such as the valve frame 40 of FIG. 4B. The valve assembly110 is constructed from a mesh 112. The mesh 112 is constructed from,for example, wires or strips of shape memory material as previouslydescribed herein.

Referring now to FIGS. 11A, 11B and 11C, the valve assembly 110 hasthree valve gaps 111 a, 111 b and 111 c which each act as a hinge pointfor a cover material, for example, the cover material 56 of FIG. 5C.Valve gap 111 b is shown in hidden view in FIG. 11B for clarity ofillustration purposes.

The cover material 56 could be a biocompatible material, such as,silicon rubber or bovine, porcine or human tissue that is chemicallytreated to minimize the likelihood of rejection by the patient's immunesystem. The cover material 56 is not shown in FIG. 11B for clarity ofillustration purposes. The cover material 56 would be applied to thevalve assembly 110 prior to deployment of the valve assembly 110 intothe body. The cover material could be, for example, sutured to the valveassembly 110 in a location 118 a, 118 b and 118 c (118 b is not shownfor clarity of illustration purposes). Subsequent to placement of thevalve assembly 110 within the body, the cover material 56 is capable of,generally, permitting the flow of blood in the positive direction alongthe X-axis, as previously described herein.

The valve assembly 110 is capable of being compressed as describedpreviously herein and loaded into an introducing catheter, such as theintroducing catheter 61 of FIG. 6. Subsequent to insertion of theintroducing catheter 61 into the heart of a patient and locating theintroducing catheter 61 in a desirable location, an operator deploys thevalve assembly 110 from the introducing catheter 61. The valve assembly110 then expands because the introducing catheter 61 no longer applies aconstraining force to the valve assembly 110. Alternatively, a balloon,such as the balloon 73 of FIG. 7 could be used, as described previouslyherein, to expand the valve assembly 110.

The valve assembly 110, alternatively, could be expanded by heating theshape memory material once the valve assembly 110 is located in adesirable location in the heart. The valve assembly could warm due tocontact with, for example, heart tissue or blood of the patient.

However, as blood flows in the negative direction along the X-axis thefree ends 119 a, 119 b and 119 c (the free end 119 b is not shown forclarity of illustration purposes) of the cover material 56 move awayfrom an inner wall 115 of the valve assembly 110. The cover material 56,thereby, generally restricts the flow of blood through the valveassembly 110. In this manner, the valve assembly 110 approximates thefunctioning of a natural heart valve of the body by preventing the flowof blood along the negative direction along the X-axis.

The valve gaps 111 a, 111 b and 111 c could be of any suitable shape(e.g., leaf shaped, oval shaped or generally polygonal shaped) and anynumber (e.g., three, four or six) such that depending upon the directionof the flow of blood, the flow of blood is either adequately blocked orpermitted by the presence of the cover material 56 located on the valveassembly 110. Additionally, the alternative shapes and number of valvegaps must also allow for the valve assembly to be loaded into andunloaded from an introducing catheter, such as the introducing catheter61 of FIG. 6.

FIGS. 14A and 14B are digital images of a model 140 of a valve assembly,such as the valve assembly 110 of FIGS. 11A and 11B, respectively. Forclarity of illustration purposes the valve assembly model 140 isconstructed from a tube 142 and a silicon rubber cover material 144. Thevalve assembly model 140, referring now to FIG. 14B, is cylindrical inshape. The valve assembly model 140, alternatively, could be anygeometric shape as described previously herein.

In another embodiment, now referring to FIGS. 12A and 12B, a valveassembly 120 has three valve gaps 11 a, 11 b and 11 c (the valve gap 111b is not shown for clarity of illustration purposes). The valve assembly120 also has two openings 121 a and 121 c. The openings 121 a and 121 c,for example, could represent openings in the valve assembly 120 that arein fluid communication with two coronary arteries in the heart. Due tothe presence of the valve openings 121 a and 121 c, less material isrequired to fabricate the valve assembly 120. As such, it may bepossible to use a smaller diameter, introducing catheter, such as theintroducing catheter 61 of FIG. 6 to introduce the valve assembly 120into the heart of the patient.

FIGS. 15A and 15B are digital images of a model 150 of a valve assembly,such as the valve assembly 120 of FIG. 12A. For clarity of illustrationpurposes the valve assembly model 150 is constructed from a tube 152 anda silicon rubber cover material 154. The valve assembly model 150,referring now to FIG. 15B, is cylindrical in shape. The valve assemblymodel 150, alternatively, could be any geometric shape as describedpreviously herein.

As shown in FIG. 16, another embodiment of a stent 30 is illustrated. Inthis embodiment, the stent 30 approximates the form of a cloverleaf toclosely conform, for example, to the cloverleaf-like shape (associatedwith the three sinuses of a natural heart valve) of the location in aheart where a defective heart valve has been surgically removed. Thestent 30 defines a generally cylindrical, elongated body that has a wall34 that is constructed from a mesh 32. The wall 34 defines a lumen 36.The mesh 32 is constructed from, for example, wires or strips of shapememory material or other alternative materials as earlier described.

Referring again to FIG. 16, the lumen 36 of the stent 30 includes a neckportion 37 that can accommodate a partially deployed valve frame 40 (avalve frame 40 is illustrated in FIG. 17). The stent 30 also includes atapered portion 38 extending from a distal end 31 of the stent 30 and abulbous portion 35 extending from a proximal end 33 of the stent 30.

Enabling a valve frame 40 to partially deploy within the stent 30 isbeneficial, since the valve frame 40 can be repositioned in the stent 30prior to being fully deployed in the stent 30. Repositioning the valveframe 40 may be necessary, for instance, to ensure a proper alignment ofthe valve frame 40 within the lumen 36 of the stent 30 so that movementof the valve frame 40 with respect to the stent 30 is minimal once thevalve frame 40 is fully deployed.

FIG. 17 illustrates one embodiment of a valve frame 40 in deployed form(i.e., not constrained by, for example, a wall of a lumen of a catheterused to introduce the valve frame 40 into the body). The valve frame 40may be deployed within a stent, such as the stent 30 of FIG. 16 and canbe constructed as described earlier with reference to FIGS. 4A-4B.

As earlier described, the valve frame 40 may be deployed within thelumen 36 of the stent 30 thereby creating a valve assembly 50 (FIG.18E). In one embodiment, the valve assembly 50 is deployed within ahuman heart to replace a natural heart valve that is not functioningproperly. The valve frame 40 and the stent 30 are manufactured to ensurethat the valve frame 40 maintains a desired (e.g., fixed) placement withrespect to the stent 30 when the valve frame 40 and the stent 30 arelocated within the heart of a patient and subjected to the flow of bloodthrough the valve assembly 50.

In more detail and with reference to FIGS. 18A-18E, method stepsassociated with introducing an embodiment of the invention into ananatomical lumen are described. As an initial step, with the aid of afluoroscope, an introducing catheter 61 is delivered via a vessel to theheart by means of a guidewire 62 to a preselected position in ananatomical lumen of the heart. The preselected position may be, forinstance, in proximity to the original location of a natural heartvalve. The introducing catheter 61 has an inner wall 69 that defines alumen 64 through which the guidewire 62 is passed. The introducingcatheter 61 has an opening 66 out of which the guidewire 62 is extended.In an alternative embodiment, a catheter may be inserted and maneuveredwithin a patient without the use of a guidewire 62.

With reference to FIG. 18A, the stent 30 is compressed and inserted intothe introducing catheter 61, and the stent 30 is guided in a distaldirection to the catheter orifice 66 over the guidewire 62.Alternatively, the guidewire 62 may be removed, and the stent 30 may beguided through the introducing catheter 61 to the catheter orifice 66using the walls 69 of the introducing catheter 61 as a guide.

Once the stent 30 reaches the catheter orifice 66, the stent 30 isguided through the orifice and into the body. The stent 30 may beexpanded to a predetermined configuration and size, using methodspreviously described. The expanded configuration of the stent 30conforms to a region of the anatomical lumen (not shown) and in oneembodiment, the size and shape of the stent 30 is sufficient to hold thestent 30 in a substantially fixed position and orientation within theanatomical lumen. Alternatively, as earlier described, the stent 30includes elements (e.g., sutures, hooks, spikes or tack tips) thatattach to the interior walls of the anatomical lumen so as to morerigidly hold the stent 30 in a fixed position.

Referring to FIG. 18B, after the stent 30 is inserted into the body, thevalve frame 40 is compressed and inserted into the introducing catheter61. Like the stent 30, the valve frame 40 is guided in a distaldirection to the catheter orifice 66 over the guidewire. Alternatively,the guidewire 62 may be removed, and the valve frame 40 may be guidedthrough the introducing catheter 61 to the catheter orifice 66 using thewalls 69 of the introducing catheter 61 as a guide.

Referring to FIG. 18C, once the valve frame 40 reaches the catheterorifice 66, the valve frame 40 is partially deployed into the neckportion 37 of the elongated lumen 36 of the expanded stent 30. Theelongated stent 30 and the elongated body of the valve frame 40 enablethe valve frame 40 to be partially deployed in the stent 30. In thepartially deployed state, the valve frame 40 may still be retracted intothe introducing catheter 61, and re-positioned within the stent 30 ifnecessary. Upon being partially deployed, a distal end 47 of the valveframe 40 expands and assumes substantially the same size and shape asthe lumen 36 of the expanded stent 30. A determination is then made, forexample, using fluoroscopy, as to whether the valve frame 40 is properlypositioned within the stent 30. To be properly positioned, the distalend 47 of the valve frame should align as shown in FIG. 18C with thetapered portion 38 of the stent 30. If a determination is made that thestent 30 and the valve frame 40 are not in proper alignment, the valveframe 40 can be retracted into the introducing catheter 61, and thenre-deployed at the proper location within the stent 30.

Once the valve frame 40 is properly aligned with the stent 30, the userfully releases the valve frame 40 into the stent 30, and withdraws thecatheter 61 (FIGS. 18D-18E). When the valve frame 40 is fully deployedwithin the stent 30, the valve frame 40 expands, and adjusts tosubstantially correspond with the shape of the stent 30, such that theouter surfaces of the valve frame 40 mate with the inner surfaces of thestent 30. The mating surfaces of the valve frame 40 and the stent 30maintain the positioning of the valve frame 40 within the stent 30. Forexample, the distal end 47 of the valve frame 40 engages with taperedportion 38 of the stent 30, and the valve members 44 a, 44 b, and 44 cexpand to engage the bulbous portion 35 of the stent 30.

Referring to FIGS. 19A-19E, in other embodiments, the stent/dockingstation 130 may be any geometric shape (e.g., cylindrical, conical,spherical or barrel-like) that is compatible with the placement of thedocking station 130 within, for example, a lumen of the heart or in aureter. The illustrated docking stations 130 may be made from the stentmaterials described earlier. The docking stations 130 when inserted intothe body may hold a variety of devices in addition to valves. Forexample, referring to FIG. 19A, the docking station 130 includes apocket that receives a capsule of medicine. The capsule may be held inplace by frictional engagement with the docking station 130. Forexample, dimples may protrude inwardly from the inner surface of thedocking station 130 to engage the capsule. Referring to FIG. 19C, inanother embodiment, the docking station 130 includes an external annularring 131 that may hold a pressure responsive valve and/or sphincter 132to reduce the flow of fluids in a body cavity. In another embodiment asillustrated in FIG. 19D, the docking station 130 includes a recessedsurface or cavity 133 that may hold a monitoring device, such as a videocamera or heart rate monitor. Referring to FIG. 19E, the docking station130, in one embodiment, forms a closed body to receive a medical device,drug, or radiation source. In one embodiment, the drug is a slow releasemedication formulation. The closed end 134 of the docking station 130may be coupled to a mounting device 136 that is used to secure thedocking station 130 in the body.

Referring to FIGS. 20A-20F, the docking station 130 is shown insertedinto various locations of the body including a blood vessel (FIG. 20A),the brain (FIG. 20B), a ureter (FIG. 20C), the stomach (FIG. 20D), thecolon (FIG. 20E), and the heart (FIG. 20F). In general, the dockingstation 130 may be inserted into any cavity, organ, vessel, valve,sphincter, or lumen of the body. The docking station 130 may be insertedthrough a catheter, as described above with reference to FIGS. 18A-18E.Once the docking station 130 is placed in the body, the docking station130 may receive medical devices that either temporarily or permanentlycouple with the docking station 130 as described above. As an example,as illustrated in FIG. 20B, a drug/radiation source may be inserted intoa docking station 130 located in the brain to treat a seizure focus, amalignancy, or to repair damaged tissue. Alternatively, referring toFIGS. 20C and 20D, a docking station 130 mounted in the stomach or aureter may couple to a pressure responsive valve and/or sphincter (FIG.19C) to prevent reflux. Referring to FIG. 20E, in another embodiment, adocking station 130 similar to the docking station 130 illustrated inFIG. 19D may be inserted into the colon. The docking station 130 maythen receive a monitoring device to provide feedback to care providers.Referring to FIG. 20F, as another example, a heart rate monitor, anelectrocardiogram sensor, or a pacemaker may be coupled to a dockingstation 130 implanted in the heart. One advantage of the currentinvention is that if a medical device or a drug is no longer required,the medical device or drug may be removed from the docking station 130,with the docking station 130 remaining in place within the body forfuture use with another medical device or drug.

In another embodiment (FIG. 21) the replacement valve assembly 310includes a stent 330 and valve frame 340. The stent 330 is expandablebetween a first compressed state (shown) and a second expanded state(not shown). The stent 330 has a cylindrical body constructed from aplurality of serpentine wires (generally 331). Each of the serpentinecurves of a first wire 331 is attached at the vertices 333 to each ofthe serpentine curves of an adjacent wire 331. In one embodiment thewires 331 are constructed of stainless steel. At each end of the stent330 is an additional serpentine shaped end wire (generally 334) havingserpentine curves of smaller radius. Several of the vertices of each ofthese serpentine end wires 334 are attached to several of the vertices336 other serpentine wires 331 of the body.

Referring also to FIG. 22, the valve frame 340 includes a substantiallycylindrical body portion 341, a plurality of valve attachment pairs 346,and optionally a plurality of standoffs 350 attached to one or moreexterior serpentine wire rings 353.

The substantially cylindrical body portion 341 of the valve frame 340 isconstructed of a plurality of serpentine curved wires 352. Each of thevertices 356 of the serpentine curves of a first wire 352 is attached atthe vertices 356 to each of the vertices of the serpentine curves of anadjacent wire 352. In one embodiment the wires 352 are constructed ofNitinol. Again the substantially cylindrical body portion 341 isexpandable between a first compressed state (not shown) and a secondexpanded state (shown). It should be noted that when the terms vertex ortrough are used, the convention is that the word trough is a bend in thewire that points in the direction of blood flow and a vertex is a bendthat points in a direction opposite blood flow.

At one end of the cylindrical body 341 of the valve frame 340 are threesets of valve attachment pairs 346. Each valve attachment pair 346includes an inner curved wire 358 and an outer curved wire 360. Eachcurved wire 358, 360 is attached either to a vertex 362, 364(respectively as shown in FIG. 21) or to a trough 372 and vertex 370(respectively as shown in FIG. 22). In one embodiment, (FIG. 22) thespace S between the inner curved wire 358 and the outer curved wire 360is substantially parabolic and constant.

To each valve attachment pair 346 is attached a leaflet 390 (FIGS. 23,24 and 25). Each leaflet 390 has a leaflet body 396 and a plurality ofleaflet projections 392. When attached to the valve frame 340, theleaflet body 396 is located within the lumen of the valve frame 340.Referring to FIG. 25, the leaflet 390 is positioned such that theportion of the leaflet body 396 nearest the projections 392 is pulledover the outer curved wire 360 and the leaflet projections 392 arecurved over the inner curved wire 358. Each leaflet projection 392 isattached by sutures 394 to itself. This anchors the leaflet projection392 to the inner curved wire 358 and permits the leaflet body 396 to besecured and maintain its shape within the lumen of the valve frame 340.This configuration prevents the sutures 394 from being exposed to bloodpassing through the valve and provides free motion of the leaflet bodywithout any contact to prosthetic materials thereby preventing damage tothe leaflet.

Further, by placing the attachment of the outer 360 and inner 358 curvedwires to the body 341 of the valve frame 340, at adjacent vertices 370and troughs 372, the distance between the inner 358 and outer 360 curvedwires is substantially assured. As a result, the movement of the valveleaflets 390 does not cause the curved wires 358, 360 to touch, therebypreventing damage to the leaflets 390.

In one embodiment an optional plurality of standoffs 350 hold one ormore exterior serpentine rings 353 at a distance away from the outercurved wire 360 to provide extra support to the valve frame 340. Atseveral locations on the exterior serpentine ring(s) 353 are locatedplatinum markers 400. In one embodiment (shown) platinum wire is wrappedabout the exterior serpentine ring(s) 353 in several locations. Theselocations then serve as radiopaque markers 400 to help position thevalve frame 340 within the stent 330. In another embodiment the platinummarkers are also positioned on the opposite end of the valve frame sothat both ends of the valve frame 340 can be seen clearly underfluoroscopy as the valve frame 340 is positioned within the stent 330.Each standoff 350 must be long enough so that when the valve frame 340is compressed to fit within a catheter, the leaflet 396 which is turnedover the outer wire 360 does not contact the exterior serpentine ring353 thereby potentially causing damage to the leaflet 390.

FIG. 26 depicts a similar valve frame but one in which the inner 358 andouter 360 curved wires are attached to the same location 404 on verticesof wire 352 of the cylindrical body 352.

In use, the stent 330 is inserted into position in the heart through acatheter as described previously with respect to other embodiments. Anelongate balloon is introduced through a catheter into the lumen of thestent 330. The balloon is inflated within the stent 330 and the stent330 expands radially substantially uniformly along its length. Then asubstantially spherical balloon is introduced into middle the expandedstent 330 and inflated. This additional inflation causes the centerregion of the stent 330 to expand further causing the stent 330 to takeon a barrel shape.

Next the compressed valve frame 340 with attached leaflets 396 isintroduced into the stent 330 through a catheter and permitted toexpand. The tapered ends of the barrel shape of the stent 330 holds thevalve frame 340 in place even when the closed valve results in pressurebeing placed on the valve frame 340 due to the stopped blood flow.

Other embodiments incorporating the concepts disclosed herein may beused without departing from the spirit and scope of the invention. Thedescribed embodiments are to be considered in all respects as onlyillustrative and not restrictive.

1. A replacement heart valve comprising: a valve frame comprising a bodydefining a lumen, wherein the body of the valve frame comprises: asubstantially cylindrical body portion, wherein one end of thesubstantially cylindrical body portion comprises a serpentine edgecomprising a plurality of troughs and vertices; one or more exteriorserpentine rings at a distance away from the substantially cylindricalbody portion; a plurality of valve attachment wires between the one ormore exterior serpentine rings and the substantially cylindrical bodyportion, the plurality of valve attachment wires comprising a pluralityof curved wire pairs, wherein each curved wire pair comprises an innercurved wire and an outer curved wire; and a plurality of standoff wiresattached to the one or more exterior serpentine rings and thesubstantially cylindrical body portion; and a plurality of valveleaflets attached to the valve attachment wires; wherein the ends ofeach inner curved wire is attached to spaced apart vertices of theserpentine edge, and the ends of each outer curved wire is attached tospaced apart troughs of the serpentine edge, wherein the serpentine edgeis constructed and arranged such that, in use, each vertex points to adirection opposite blood flow, and each trough points to the directionof blood flow.
 2. The replacement heart valve of claim 1, wherein theinner curved wire and the outer curved wire are separate from each otherby a space that is substantially constant.
 3. The replacement heartvalve of claim 1, wherein the inner curved wire and the outer curvedwire are parabolic in curvature.
 4. The replacement heart valve of claim1, wherein each valve leaflet comprises a leaflet body and one or moreleaflet projections, wherein the one or more leaflet projections arecurved around a respective inner wire and attached to itself, and theleaflet body extends over a respective outer curved wire.
 5. Thereplacement heart valve of claim 4, wherein each leaflet is positionedsuch that the leaflet body is located within the lumen of the valveframe, the portion of the leaflet body nearest the one or more leafletprojections is pulled away from the lumen over a respective outer curvedwire and toward a respective inner curved wire to position the one ormore leaflet projections such that they are extended toward the lumenand curved around the respective inner curved wire.
 6. The replacementheart valve of claim 1, comprising one or more radiopaque markers at theone or more exterior serpentine rings.
 7. The replacement heart valve ofclaim 1, comprising one or more radiopaque markers at the substantiallycylindrical body portion.
 8. The replacement heart valve of claim 1,wherein the substantially cylindrical body portion is constructed of aplurality of serpentine curved wires.
 9. The replacement heart valve ofclaim 8, wherein each serpentine curved wire is composed ofnickel-titanium.
 10. The replacement heart valve of claim 1, whereineach standoff wire is sufficiently long to prevent contact between thevalve leaflets and the exterior serpentine rings when the valve frame isin a compressed state.